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Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06161376
Acronym
SEP-1
Enrollment
400
Registered
2023-12-07
Start date
2023-12-04
Completion date
2027-12-31
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.

Interventions

OTHERS1P level

Patients will undergo urinary S1P level assessments before treatment, 6 weeks post-injection, and following any symptomatic changes that may lead to another urodynamic assessments.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

Inclusion criteria

* French residents enrolled in the social security system * Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not * Patients scheduled for urodynamic assessment as part of their management

Exclusion criteria

* Pregnant or lactating females * Patients under legal guardianship * Untreated urinary tract infection at the time of inclusion * Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty

Design outcomes

Primary

MeasureTime frameDescription
S1P concentrationDay 0, after 6 monthsTo compare of the urinary concentration of S1P related to creatinine in urine sample, as a function of the detrusor activity determined at BUD, before and after a first intra-detrusor injection of botulinum toxin.

Countries

France

Contacts

Primary ContactXavier Game, MD
game.x@chu-toulouse.fr05 61 32 33 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026